Quality Assurance Associate - on the floor

Elanco; Winslow (ME); On-site; USD 55,000 - 75,000; Full time

Job summary

Elanco is seeking a Quality Assurance Associate to join their team in Winslow, Maine. In this role, you will support cGMP operations, maintain quality systems, and ensure compliance across manufacturing processes.

The ideal candidate will possess a Bachelor’s degree in a related field and experience in quality systems or regulated environments. Strong problem-solving skills and effective communication are essential. Elanco values diversity and champions new ways of thinking in a supportive workplace environment.

Qualifications

• Experience in quality systems, manufacturing, or regulated environments.

Responsibilities

• Support batch disposition for incoming, in-process, and finished materials.
• Review and approve quality documents including deviations, change controls, and validation protocols.
• Partner cross-functionally to investigate non-conformances and drive CAPAs.
• Provide guidance to operations teams to ensure compliance with quality systems and regulatory standards.
• Support internal and external audits and contribute to continuous improvement initiatives.

Skills

Strong problem-solving/root cause analysis

Effective communication and collaboration

Education

Bachelor’s Degree in a Science or Engineering field (or equivalent experience)

Job description

At Elanco (NYSE: ELAN) – it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People.

At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, works with dynamic individuals, and acquires new skills and experiences that will propel your career to new heights.

Making animals’ lives better makes life better – join our team today!

Your Role

Quality Assurance Associate

As a Quality Assurance Associate, you will be part of the Quality team to support cGMP operations and ensure compliance across manufacturing processes. In this role, you will be responsible for maintaining quality systems, supporting batch disposition, and partnering cross-functionally to drive compliance, investigations, and continuous improvement.

Your Responsibilities

• Support batch disposition for incoming, in-process, and finished materials
• Review and approve quality documents including deviations, change controls, and validation protocols
• Partner cross-functionally to investigate non-conformances and drive CAPAs
• Provide guidance to operations teams to ensure compliance with quality systems and regulatory standards
• Support internal and external audits and contribute to continuous improvement initiatives

What You Need to Succeed (minimum qualifications)

• Education: Bachelor’s Degree in a Science or Engineering field (or equivalent experience)
• Experience: Experience in quality systems, manufacturing, or regulated environments
• Top 2 skills: Strong problem-solving/root cause analysis + effective communication and collaboration

What will give you a competitive edge (preferred qualifications)

• Experience in pharmaceutical, biotech, or regulated (FDA/USDA) environments
• Knowledge of Lean, Six Sigma, or Operational Excellence methodologies
• Experience with deviations, CAPAs, and quality investigations
• Strong technical writing and documentation review skills
• Ability to lead and influence in a cross-functional team environment

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job-related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.